Peter Reichardt1, Marcus Schlemmer2, Juan R Delgado Perez3, Zsuzsanna Papai4, Jana Prausova5, Bohuslav Melichar6, Elena Fumagalli7, Carlo Barone8, Sebastian Bauer9, Anette Pustowka10, Stefania Crippa11, Ramon Castellana12, Claudia Quiering10, Axel Le Cesne13. 1. Department of Oncology and Palliative Care, Sarcoma Center Berlin-Brandenburg, Helios Klinikum Berlin-Buch, Berlin, Germany. 2. Department of Internal Medicine III, University Hospital Grosshadern, Ludwig-Maximilians-Universität München, Munich, Germany, Marcus.Schlemmer@barmherzige-muenchen.de. 3. Department of Medical Oncology, University Hospital Virgen de las Nieves, Granada, Spain. 4. Department of Oncology, Medical Centre, Hungarian Defense Forces, Budapest, Hungary. 5. Department of Oncology, University Hospital Motol, 2nd Faculty of Medicine, Charles University, Prague, Czechia. 6. Department of Oncology, Palacky University Medical School and Teaching Hospital Olomouc, Olomouc, Czechia. 7. Adult Mesenchymal Tumour and Rare Cancer Medical Oncology Unit, Cancer Medicine Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 8. Division of Medical Oncology, University Hospital A. Gemelli, Rome, Italy. 9. Department of Medical Oncology, Sarcoma Center, West German Cancer Center, University Hospital, University of Duisburg-Essen, Essen, Germany. 10. Novartis Pharma GmbH, Nuremberg, Germany. 11. Oncology Region Europe, Origgio, Italy. 12. Novartis Farmacéutica, Barcelona, Spain. 13. Department of Medical Oncology, Gustave Roussy Institute of Oncology, Villejuif, France.
Abstract
BACKGROUND: Gastrointestinal stromal tumors (GISTs) are mesenchymal tumors most often caused by activating mutations of the KIT gene. KIT tyrosine kinase inhibitors provide targeted therapy for the underlying genetic mutation, and adjuvant therapy is indicated for patients who are at significant risk of relapse following GIST resection. This is a report of the safety of imatinib in patients with GIST in the adjuvant setting in an expanded access program. METHODS: In this multicenter, open-label, single-arm trial, safety was assessed based on the frequency of adverse events (AEs). RESULTS: Three hundred patients were treated and analyzed; 40 patients discontinued treatment. Median overall exposure during the program was 181 days (range 9-420); most patients (260/300 treated) completed the study. Six patients had disease recurrence, 4 of whom discontinued. In line with previously published reports, the most frequent AEs were nausea, diarrhea, and periorbital edema. The AEs were mild to moderate in most cases (76%). CONCLUSIONS: These findings are in agreement with the known safety profile of imatinib and confirm the safety of imatinib at 400 mg/day in the adjuvant setting. The incidence of severe AEs was low.
BACKGROUND:Gastrointestinal stromal tumors (GISTs) are mesenchymal tumors most often caused by activating mutations of the KIT gene. KIT tyrosine kinase inhibitors provide targeted therapy for the underlying genetic mutation, and adjuvant therapy is indicated for patients who are at significant risk of relapse following GIST resection. This is a report of the safety of imatinib in patients with GIST in the adjuvant setting in an expanded access program. METHODS: In this multicenter, open-label, single-arm trial, safety was assessed based on the frequency of adverse events (AEs). RESULTS: Three hundred patients were treated and analyzed; 40 patients discontinued treatment. Median overall exposure during the program was 181 days (range 9-420); most patients (260/300 treated) completed the study. Six patients had disease recurrence, 4 of whom discontinued. In line with previously published reports, the most frequent AEs were nausea, diarrhea, and periorbital edema. The AEs were mild to moderate in most cases (76%). CONCLUSIONS: These findings are in agreement with the known safety profile of imatinib and confirm the safety of imatinib at 400 mg/day in the adjuvant setting. The incidence of severe AEs was low.
Authors: Deborah van de Wal; Mai Elie; Axel Le Cesne; Elena Fumagalli; Dide den Hollander; Robin L Jones; Gloria Marquina; Neeltje Steeghs; Winette T A van der Graaf; Olga Husson Journal: Cancers (Basel) Date: 2022-04-05 Impact factor: 6.639